FDASeptember 2, 2020device
GENTIAN Cystatin C Calibrator and Calibrator Kit, for the following models: 1. Gentian C E, Cystatin C Calibrator, 1 x 1 mL, REF 1012, UDI: (01)07090038460092 2. Gentian C E Calibrator Kit, 6 x 1 mL, REF 1051, UDI: (01)07090038460108 3. Gentian C E, BCI Ref: A52763, Cystatin C calibrator Kit, 6 x...
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
The firm has identified lots of calibrators that have shown to measure incorrect high values over time compared to the assigned values when released for distribution. This could result in higher Cystatin C values measured in patients.
What to do
FDA enforcement status: Terminated
Brands named
gentian asgentian
Recall history
No related federal recalls on record for this brand yet.
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